Next week, the US Pharmacopeia (USP) is hosting the 10th International Symposium on Pharmaceutical Reference Standards in Rockville, MD. The annual PDA-FDA meeting also happens to be taking place next week in Washington, DC, so industry has much to hope for in terms of regulatory news. Read more »
Archive for the 'Formulation' Category
Pharmaceutical companies sometimes explain their unimpressive pipelines by saying that it’s become harder to discover and develop new drugs. Believing that the low-hanging fruit has been picked already, manufacturers are focusing on serving small patient populations. But a new paper suggests that the industry may be overlooking the potential of a particular class of drugs to treat tens of millions of patients. Read more »
Pfizer Global Engineering and Manufacturing has been working with students and faculty from Rowan University’s chemical engineering department to investigate green approaches to drug manufacturing, according to a July Rowan press release. The partnership is aimed at analyzing and quantifying the economic viability and environmental benefit, respectively, of investing in a small solvent-recovery system. Such a system provides an alternative to incineration for small volumes of waste. Read more »
It’s been four years since the International Conference on Harmonization adopted ICH Q3B(R2), which harmonizes the content and qualification of impurities in drug substances, including extractables and leachables (E&L) produced by the interaction of a drug substance and its container-closure system. And yet, there still seem to be a huge amount of questions surrounding these degradation byproducts, stability testing, thresholds, and reporting requirements.
Legislators and regulators on both sides of the Atlantic have spent the past decade trying to improve access to safe and effective pediatric formulations and drug products—but it’s unclear whether pharma companies are taking notice. Read more »
Vetter, a specialist in the aseptic filling of injection systems, opened a new 24,000-ft2 facility in Chicago to manufacture preclinical, Phase I and Phase II clinical batches. The expansions, part of the new Vetter Develoment Services USA Inc., complement the company’s commercial-scale capabilities in Germany. PharmTech Europe Editor Fedra Pavlou, interviewed Peter Soelkner, managing director of Vetter Pharma International GmbH live from the AAPS 2009 show floor in Los Angeles last month. Listen to the podcast here.
See background article, “Vetter Expands Clinical- and Commercial-Scale Operations” by Patricia Van Arnum.
ISP Pharmaceuticals is embarking on a drug-solubility Initiative to support pharma companies working with poorly soluble drug actives. At a press conference held at CPhI Worldwide in Madrid, Spain, on Wednesday, the company explained that a huge amount of drugs in the pharmaceutical developmental pipeline present solubility issues. Read more »
Last week, I wrote that the increased attention to biological drugs, which are mostly taken through injections, was spurring interest in needle-free and implantable delivery methods for vaccines. Research into alternative delivery methods for vaccines could produce innovative ways of delivering other kinds of drugs as well, and I recently read about an inspired idea that a team of Boston researchers had for delivering intermittent doses of drugs. Read more »
Have you ever considered getting a flu shot but quailed at the sight of the needle? Lots of people hate getting injections, but this delivery method is still the predominant technique for administering biological drugs. Rising demand for vaccines and other biologicals is one factor spurring manufacturers to seek alternative delivery methods that could one day rescue the needlephobic. Read more »
Efforts toward drug formulations that take into account genetic makeup will require a new examination of how disease develops in the body, thereby making it possible to connect biology with the chemical functions of a drug’s active ingredient. Read more »